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Evaluation of the Pharmacokinetic Interaction Between Candesartan and Felodipine After Ingestion of a Specific Meal

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT00905333
First Posted: May 20, 2009
Last Update Posted: December 7, 2010
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Collaborators:
Scentryphar Clinical Research
Cori Analyticals
Clínica São Lucas, Hospital Sírio Libanês de Itatiba S/C
LabClin Laboratório Clínico
Laboratório de Patologia Clínica Dr. Franceschi Ltda.
Faculdade de Ciências Farmacêuticas de Ribeirão Preto - Centro de Bioequivalência
Information provided by:
AstraZeneca
  Purpose
The purpose of this study is to evaluate the pharmacokinetic interaction of test formulations of candesartan and felodipine in a combination package comparing with the fasting intake of commercial formulations of both Atacand ® and Splendil®

Condition Intervention Phase
Healthy Drug: Candesartan (test) Drug: Felodipine (test) Drug: Candesartan Cilexetil Drug: Felodipine Phase 1

Study Type: Interventional
Study Design: Intervention Model: Crossover Assignment
Masking: None (Open Label)
Official Title: Evaluation of the Pharmacokinetic Interaction Between Candesartan and Felodipine in a Combination Package Compared to the Separate Intake of the Reference Brands Atacand and Splendil After a Fasting Period.

Resource links provided by NLM:


Further study details as provided by AstraZeneca:

Primary Outcome Measures:
  • Kinetic interaction evaluation of two test formulations of 16 mg of candesartan and 5 mg of felodipine after a fasting period and the comparison with the intake of both reference medicaments: Atacand® and Splendil®. [ Time Frame: 76 blood samples per subject ]

Enrollment: 36
Study Start Date: October 2008
Study Completion Date: November 2008
Primary Completion Date: November 2008 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Single-arm
3 treatments, 6 sequences, 3 periods, cross-over, single dose arm (Willians' Plan)
Drug: Candesartan (test)
16 mg oral tablet, single dose
Drug: Felodipine (test)
5 mg oral extended release tablet, single dose
Drug: Candesartan Cilexetil
16 mg oral tablet, single dose
Other Name: Atacand®
Drug: Felodipine
5 mg oral extended release tablet, single dose
Other Name: Splendil®

  Eligibility

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 50 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • Healthy volunteers
  • BMI > or = 19 and < or = 28 (Dietary Guidelines Advisory Committee, 2005)

Exclusion Criteria:

  • Not healthy
  • Chronic drug intake
  Contacts and Locations
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00905333


Locations
Brazil
Research Site
Itatiba, SP, Brazil
Research Site
Americana, Brazil
Sponsors and Collaborators
AstraZeneca
Scentryphar Clinical Research
Cori Analyticals
Clínica São Lucas, Hospital Sírio Libanês de Itatiba S/C
LabClin Laboratório Clínico
Laboratório de Patologia Clínica Dr. Franceschi Ltda.
Faculdade de Ciências Farmacêuticas de Ribeirão Preto - Centro de Bioequivalência
Investigators
Principal Investigator: Eduardo Abib Junior, MD Scentryphar Clinical Research
Study Chair: Moises L. P Vanuncci, MD Scentryphar Clinical Research
  More Information

Responsible Party: MC MD, AstraZeneca
ClinicalTrials.gov Identifier: NCT00905333     History of Changes
Other Study ID Numbers: D2452L00021
IMPACT 15381
First Submitted: May 19, 2009
First Posted: May 20, 2009
Last Update Posted: December 7, 2010
Last Verified: December 2010

Keywords provided by AstraZeneca:
pharmacokinetics
candesartan
felodipine
test formulations
Atacand®
Splendil®
healthy volunteers
blood samples
after meal intake interaction
Kinetic interaction amongst test formulations of Candesartan and Felodipine and the brands Atacand® and Splendil® in healthy volunteers after a fasting period.

Additional relevant MeSH terms:
Candesartan
Candesartan cilexetil
Felodipine
Antihypertensive Agents
Angiotensin II Type 1 Receptor Blockers
Angiotensin Receptor Antagonists
Molecular Mechanisms of Pharmacological Action
Anti-Arrhythmia Agents
Calcium Channel Blockers
Membrane Transport Modulators
Vasodilator Agents